UMIN ID: UMIN000056116
Registered date:15/11/2024
Effect of amino acid mixture on blood glucose
Basic Information
Recruitment status | Pending |
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Health condition(s) or Problem(s) studied | Healthy adults who feel they do not get enough physical activity |
Date of first enrollment | 2024/11/16 |
Target sample size | 50 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | amino acid mixture, single dose foods not containing amino acid mixture, single dose |
Outcome(s)
Primary Outcome | Blood glucose levels |
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Secondary Outcome | Insulin concentration Amino acid concentration |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 65years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | (1)Subjects who use oral medication affecting blood glucose. (2)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting blood glucose. (3)Subjects who need medical treatment for diabetes. (4)Subjects who contract or are under treatment or are medical history for serious diseases (e.g.,liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (5)Subjects who have a operational history of digestive disease affecting digestion and absorption. (6)Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator at screening. (7)Subjects who have donated 400 mL of blood within 12 weeks prior to the start of the study and 200 mL of blood within 4 weeks and component blood donations (plasma component and platelet component blood donations) within 2 weeks prior to the start of the study. Also, considering the total amount of blood collected during the study, those who plan to donate blood within 12 weeks of the study. (8)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood. (9)Subjects who developed diarrhea or took antibiotics within one week retroactive to the examination. (10)Subjects who are planning to participate in other clinical studies. (11)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. (12)Subjects who are judged as unsuitable for the study by the investigator for other reasons. (13) Glucose tolerance test (75 g OGTT): Fasting blood glucose level greater than 110 mg/dL, or 2-hour blood glucose level greater than 200 mg/dL (14) Glucose tolerance test (75 g OGTT): The blood glucose level does not rise at all. The behavior of the blood glucose level change is N-shaped or M-shaped. |
Related Information
Primary Sponsor | KSO Corporation |
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Secondary Sponsor | |
Source(s) of Monetary Support | Ajinomoto Co., Inc. |
Secondary ID(s) |
Contact
public contact | |
Name | Kyoko MIURA |
Address | 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan Japan 210-8681 |
Telephone | 07043255184 |
kyouko.miura.jt9@asv.ajinomoto.com | |
Affiliation | Ajinomoto Co., Inc. Functional Ingredients Group Wellness Solution Development Center |
scientific contact | |
Name | Shinobu Nishitani |
Address | 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan Japan |
Telephone | 08010457701 |
shinobu.nishitani.vx8@asv.ajinomoto.com | |
Affiliation | Ajinomoto Co., Inc. Functional Ingredients Group Wellness Solution Development Center Institute of Food Sciences and Technologies Food Products Division |